Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder Wi… (NCT06594536) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
70 participantsStarted 2024-12-01
Plain-language summary
ADHD is a neurodevelopmental disorder. It is the most common neurodevelopmental disorder in children and adolescents. Its prevalence is estimated at 5.9% in this population. The symptoms of ADHD combine attention deficit with behavioural disorders such as hyperactivity and impulsivity. Current treatment for ADHD is based on psychotherapeutic and psychoeducational measures aimed at improving behaviour and its impact on the family, social and school environment. Drug treatments may also be used, depending on the impact of the disorder and the effectiveness of alternative treatments. Psychostimulants such as amphetamine derivatives and methylphenidate are around 80% effective.
Sulforaphane is an active substance derived from broccoli that has already been tested in the treatment of other neurodevelopmental disorders. The main hypothesis is that sulforaphane is effective in treating the symptoms of Attention Deficit Disorder with or without Hyperactivity (ADHD) in children.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 6 to 12
* Diagnosis of ADHD according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
* Followed or hospitalised in an investigating centre
* Consent of holders of parental authority
* Patient covered by health insurance (social security or CMU)
* Patients able to swallow capsules
Exclusion Criteria:
* Allergy to broccoli
* Psychotropic treatment including methylphenidate in the month prior to inclusion
* Ongoing psychotherapeutic and/or psycho-educational treatment specific to ADHD
* ASD (Autism Spectrum Disorder) according to DSM-5 criteria, intellectual disability (IQ\< 80)
* Chronic neurological disease, epilepsy
* Holders of parental authority under guardianship or curatorship
* Previous intake of sulforaphane
* Known hypothyroidism or current thyroid treatment
* Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, where applicable
* Patient under AME (state medical aid)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inattention scores in ADHD-RS parents
Timeframe: 8 weeks
2
Hyperactivity/impulsivity scores in ADHD-RS parents